A meeting of the Anesthesiology and Respiratory Therapy Devices Panel was held on May 28, 2009. The Panel discussed the submission, made recommendations, and voted on the Premarket Approval Application (P080009) for the Ethicon Endo-Surgery Inc. SEDASYS® Computer-Assisted Personalized Sedation System.
SEDASYS® is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as defined by the American Society of Anesthesiologists Continuum of Depth of Sedation, in adult patients (American Society of Anesthesiologists physical status I and II) undergoing colonoscopy and esophagogastroduodenoscopy (EGD) procedures. It is a first-of-a-kind device intended to enable health care providers without training in general anesthesia to administer propofol during these two procedures. Propofol is a sedative hypnotic drug only approved for use by health care providers who are trained to administer general anesthetics.
The system consists of four components. The first component is a Bedside Monitoring Unit (BMU) designed to be transported with the patient from the period immediately before the gastroenterological procedure through the procedure and through the post-procedure recovery period. The BMU contains a port to deliver oxygen by nasal cannula and an adapter for an oxygen source. The second component is the Procedure Room Unit (PRU), a patient monitor screen for peripheral hemoglobin oxygen saturation, heart rate, respiration rate, capnometry, blood pressure, and patient responsiveness. The control unit in the PRU houses the propofol infusion pump and an automated responsiveness monitor (ARM) that enables propofol to be infused if the patient responds to an auditory or vibration request by activating a hand held switch. The third component consists of reusable monitors and connectors. The final component consists of disposable devices for single patient use. This component includes a cassette with a spike which the operator will insert into the standard off-the-shelf 10 mg/mL infusion vial of propofol.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (8-2) that the application be found “Approvable with Conditions.” Five conditions were recommended and four of these were accepted prior to voting on this motion:
Condition 1: The Indications for Use should be revised to exclude EGD. There was no motion to second this condition.
Condition 2: The Indications for Use should be revised to limit the use of the device on adult patients aged 70 or less. This motion was seconded and the Panel voted (6-4) to accept this condition.
Condition 3: The device should be operated by a three person team under the direction of a physician where one person, with at least the training of a nurse, is only responsible for monitoring the device and managing the patient airway. This motion was seconded and the Panel voted (10-0) to accept this condition.
Condition 4: The device should require training for operation including advanced airway management, pharmacology of propofol and opiates, monitoring aspects of the device including capnometry, device setup, and patient selection. This training should be conducted in a facility that has been accredited to provide this type of training by persons who are credentialed by the facility to provide this type of training to health care providers. Continuing competency training and evaluation of this training may be conducted in this type of facility or in an accredited facility with validated clinical simulators.
Condition 5: The post-market study and a controlled launch of the device should be mandated. This motion was seconded and the Panel voted (9-0) with one abstention to accept this condition.
The Panel believed that the device raises the standard of care providing additional patient monitoring and the safe administration of propofol. They also believed the delivery of oxygen by the device is beneficial feature of the device. However, there were concerns regarding safety due to over sedation and the study design due to the heterogeneity (lack of standardization) of the control group, small number of sites, and the use of a surrogate endpoint. The Panel suggested further study to evaluate the safety and effectiveness of the device in patients aged greater than 70. This study, reviewed under an IDE, could then be used to support future use of the device in this population.
Contact: Neel Patel, Executive Secretary, (240) 276-4227 or Neel.Patel@fda.hhs.gov
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